Leaflet: information for the user

Bisoprolol Zentiva 1.25mg tablets EFG

Bisoprolol Zentiva 2.5mg tablets EFG

Bisoprolol Zentiva 5mg tablets EFG

Bisoprolol Zentiva 10mg tablets EFG

bisoprolol fumarate

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isBisoprolol Zentivaand what it is used for

2. What you need to know before starting to takeBisoprolol Zentiva

3. How to takeBisoprolol Zentiva

4. Possible side effects

5. Storage ofBisoprolol Zentiva

6. Contents of the pack and additional information

The active ingredient of this medication is bisoprolol. Bisoprolol belongs to a group of medications called beta blockers. These medications act by affecting the body's response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heartbeat and makes the heart more efficient, pumping blood throughout the body. At the same time, it reduces the heart's need for blood and oxygen.

This medication is used to treat chronic stable heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. It is used in combination with other suitable medications for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

In addition, bisoprolol 5 mg and 10 mg are used to treat high blood pressure (hypertension) and chest pain as a result of a deterioration of coronary blood vessel perfusion (ischemic cardiopathy: angina pectoris).

Do not take this medication

• if you are allergic to bisoprolol fumarate or any of the other ingredients in this medication (listed in section6);
• if you have severe asthma;
• if you have a late-stage vascular disease that causes an alteration in the perfusion of the arms and legs (peripheral arterial occlusive disease);
• if you have severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause tingling in the fingers of the hands and feet or make them pale or blue;
• if you have untreated phaeochromocytoma (a rare tumor of the adrenal gland);
• if you have metabolic acidosis (a condition that occurs when there is too much acid in the blood).

Do not take this medication if you have one of the following heart problems:

• acute heart failure;
• exacerbation of heart failure that requires intravenous medication to increase the heart's contraction force;
• slow heart rate (less than 50lpm);
• low blood pressure (systolic less than 90mmHg);
• specific heart conditions that cause a very slow heart rate or irregular pulse;
• cardiogenic shock(a severe and acute heart disease that causes a drop in blood pressure and circulatory failure).

If you think any of the above conditions apply to you, consult your doctor about taking this medication.

Warnings and precautions

If you have any of the following conditions, consult your doctor or pharmacist before taking this medication. They may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):

• diabetes;
• strict fasting;
• specific heart conditions such as arrhythmias or severe chest pain in rest (Prinzmetal's angina);
• kidney or liver problems;
• milder circulatory problems in the extremities;
• chronic lung disease or mild asthma;
• history of scaly skin rash (psoriasis);
• adrenal gland tumor (phaeochromocytoma);
• thyroid disorder.

Also, inform your doctor if you are going to:

• undergo desensitization treatment (for example, for hay fever prevention), because this medication may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe;
• receive anesthesia (for example, for surgery), because this medication may affect how your body reacts to this situation.

If you have chronic lung disease or mild asthma,inform your doctor immediatelyif you start to notice breathing difficulties, cough, wheezing after exercise, etc. while using this medication.

Children and adolescents

This medication is not recommended for use in children or adolescents.

Other medications and Bisoprolol Zentiva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take the following medications and bisoprolol without special advice from your doctor:

Consult your doctor before taking the following medications and bisoprolol; your doctor may need to monitor your condition more frequently:

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, ask your doctor for advice before taking this medication.

Pregnancy

There is a risk that the use of bisoprolol during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide if you can take bisoprolol during pregnancy.

Breastfeeding

The passage of bisoprolol into human breast milk is unknown. Therefore, breastfeeding is not recommended during treatment with this medication.

Driving and operating machinery

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medication. Be especially careful at the start of treatment, when the dose is increased or the medication is changed, and also in combination with alcohol.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase and at the end of treatment.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The groove is not intended to break the tablet.

The treatment with bisoprolol is usually long-term.

Chronic heart failure

Adults, including the elderly

The treatment with bisoprolol should start with a low dose and be gradually increased. Your doctor will decide how to increase the dose, and this will normally be done as follows:

The maximum recommended daily dose is 10mg of bisoprolol.

In case Bisoprolol Zentiva 1.25 mg, 3.75 mg or 7.5 mg is not marketed in your country, the doses can be achieved with other bisoprolol products available.

Depending on how well you tolerate the medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10mg of bisoprolol may be sufficient. Your doctor will tell you what to do.

Normally, if you have to discontinue treatment completely, your doctor will advise you to reduce the dose gradually, as otherwise your condition may worsen.

Hypertension

Adults, including the elderly

Unless otherwise indicated, the recommended dose of bisoprolol is 5mg per day. In the case of mild hypertension (diastolic blood pressure up to 105mmHg), treatment with 2.5mg once a day may be sufficient, using other medications at the appropriate dose.

If the effect is insufficient, the dose can be increased to 10mg per day of bisoprolol. Additional dose increase is only justified in exceptional cases.

The maximum recommended dose is 20mg per day.

Ischaemic heart disease (angina pectoris)

Adults, including the elderly

Unless otherwise indicated, the recommended dose of bisoprolol is 5mg per day.

If the effect is insufficient, the dose can be increased to 10mg per day of bisoprolol. Additional dose increase is only justified in exceptional cases.

The maximum recommended dose is 20mg per day.

Hypertension and ischaemic heart disease (angina pectoris)

Dosage in case of liver or kidney insufficiency

In patients with mild to moderate renal or hepatic insufficiency, the dose usually does not need to be adjusted. In patients with severe renal insufficiency (creatinine clearance<20ml/min) and in patients with severe hepatic insufficiency, the daily dose of bisoprolol fumarate should not exceed 10mg.

If you take more Bisoprolol Zentiva than you should

If you have taken more tablets of this medication than you should, inform your doctor immediately. Your doctor will decide what actions are necessary.

The symptoms of an overdose include decreased heart rate, severe difficulty breathing, dizziness or tremors (due to decreased blood sugar).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bisoprolol Zentiva

Do not take a double dose to compensate for the missed doses. Take your usual dose the next morning.

If you discontinue treatment with Bisoprolol Zentiva

Never stop taking this medication except on medical advice. Otherwise, your condition may worsen significantly.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

To prevent serious adverse reactions, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

The most serious side effects are related to heart function:

If you feel dizzy or débil, or have difficulty breathing, contact your médico as soon as possible.

Below are other side effects listed according to their frequency of possible occurrence:

Frequent(may affect up to 1 in 10 people):

*These symptoms are especially present at the beginning of treatment. They are usually mild and usually disappear within 1 or 2 weeks after starting treatment.

Rare(may affect up to 1 in 100 people):

Rare(may affect up to 1 in 1,000 people):

Very rare(may affect up to 1 in 10,000 people):

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and the box after CAD. The expiration date is the last day of the month indicated.

For medications packaged in OPA/Alu/PVC100//Alu or OPA/Alu/PVC60//Alu blister packs:

Store below 30°C. Store in the original packaging to protect it from moisture.

For medications packaged in white PVC/PVdC//Alu blister packs:

Store below 25°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bisoprolol Zentiva

The active ingredient is bisoprolol fumarate.

Bisoprolol 1.25 mg tablets: Each tablet contains 1.25 mg of bisoprolol fumarate.

Bisoprolol 2.5 mg tablets: Each tablet contains 2.5 mg of bisoprolol fumarate.

Bisoprolol 5 mg tablets: Each tablet contains 5 mg of bisoprolol fumarate.

Bisoprolol 10 mg tablets: Each tablet contains 10 mg of bisoprolol fumarate.

The other components are microcrystalline cellulose (PH 102); pregelatinized maize starch; crospovidone (type A); anhydrous colloidal silica and magnesium stearate.

Bisoprolol 5 mg tablets and Bisoprolol 10 mg tablets also contain yellow iron oxide (E172) and Bisoprolol 10 mg tablets also contain brown iron oxide (E172).

Appearance of Bisoprolol Zentiva and packaging contents

Bisoprolol 1.25 mg tablets: White, round tablets with a raised 1.25 and a diameter of 6 mm ± 0.3 mm.

Bisoprolol 2.5 mg tablets: White, round tablets with a raised 2.5, a groove and a diameter of 6 mm ± 0.3 mm. The groove is not intended to break the tablet.

Bisoprolol 5 mg tablets: Yellowish to light yellow, round tablets with a raised 5, a groove and a diameter of 6 mm ± 0.3 mm. The groove is not intended to break the tablet.

Bisoprolol 10 mg tablets: Ochre, round tablets with a raised 10, a groove, random colorant spots and a diameter of 6 mm ± 0.3 mm. The groove is not intended to break the tablet.

Packaging sizes:

1.25 mg: 20, 28, 30, 60, 90 or 100 tablets

2.5 mg: 15, 28, 30, 60, 90 or 100 tablets

5 mg; 10 mg: 28, 30, 50, 56, 60, 90 or 100 tablets

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing

For 2.5 mg, 5 mg and 10 mg:

ZENTIVA, k.s.

U kabelovny 130

102 37 Prague 10 – Dolní Mecholupy

Czech Republic

or

S.C. ZENTIVA S.A

B-dul Theodor Pallady nr. 50, sector 3,

Bucharest, cod 032266

Romania

For 1.25 mg:

ZENTIVA, k.s.

U kabelovny 130

102 37 Prague 10 – Dolní Mecholupy

Czech Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:June 2023

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.